Ocriplasmin: A Welcome Option for Vitreomacular Disease
Ocriplasmin: A Welcome Option for Vitreomacular Disease
Stalmans P, Benz MS, Gandorfer A, et al; MIVI-TRUST Study Group
N Engl J Med. 2012;367:606-615
Ocriplasmin, a truncated form of the serine protease plasmin, has proteolytic activity against 2 major components of the vitreoretinal interface: fibronectin and laminin. The efficacy and safety of ocriplasmin were investigated in 2 multicenter, randomized, double-blind, phase 3 clinical trials that involved 652 eyes with symptomatic vitreomacular adhesion, confirmed by optical coherence tomography (OCT).
Patients were randomly assigned to receive either 1 injection of intravitreal ocriplasmin 125 µg/0.1 mL or placebo (0.1 mL vehicle without ocriplasmin) in ratios of 2:1 or 3:1 in each trial. The primary endpoint was proportion of eyes with nonsurgical resolution of vitreomacular adhesion at day 28. Secondary endpoints included the proportion of eyes with each of the following:
The investigators found that in patients who received intravitreal ocriplasmin, the proportion of eyes with resolution of vitreomacular adhesion, nonsurgical closure of macular holes, and a gain of 3 or more lines in best-corrected visual acuity and the rate of ocular adverse events were higher. Resolution of vitreomacular adhesion was achieved in 26.5% of ocriplasmin-injected eyes and in 10.1% of placebo-injected eyes (P<.001). There was nonsurgical closure of macular holes in 40.6% of ocriplasmin-injected eyes and 10.6% of placebo-injected eyes (P<.001). Most of the ocular adverse events were transient and included those known to be associated with vitreous detachment (eg, vitreous floaters, photopsias, and blurred vision).
More patients in the ocriplasmin group also reported injection-related pain. The ocriplasmin-injected and placebo-injected eyes did not significantly differ in terms of retinal tears or detachments. Although there was no statistically significant (P≤.05) difference in the primary endpoint in patients with an epiretinal membrane (ERM) or in patients who were pseudophakic, there were differences in patients who were phakic and without an ERM and on the basis of sex (Table).
ERM = epiretinal membrane
Enzymatic Vitreolysis With Ocriplasmin for Vitreomacular Traction and Macular Holes
Stalmans P, Benz MS, Gandorfer A, et al; MIVI-TRUST Study Group
N Engl J Med. 2012;367:606-615
Ocriplasmin Trials Summary
Ocriplasmin, a truncated form of the serine protease plasmin, has proteolytic activity against 2 major components of the vitreoretinal interface: fibronectin and laminin. The efficacy and safety of ocriplasmin were investigated in 2 multicenter, randomized, double-blind, phase 3 clinical trials that involved 652 eyes with symptomatic vitreomacular adhesion, confirmed by optical coherence tomography (OCT).
Patients were randomly assigned to receive either 1 injection of intravitreal ocriplasmin 125 µg/0.1 mL or placebo (0.1 mL vehicle without ocriplasmin) in ratios of 2:1 or 3:1 in each trial. The primary endpoint was proportion of eyes with nonsurgical resolution of vitreomacular adhesion at day 28. Secondary endpoints included the proportion of eyes with each of the following:
Total posterior vitreous detachment;
Nonsurgical closure of macular hole (≤ 400 µm in diameter);
Need for vitrectomy;
Visual Function Questionnaire-25 scores (which assess quality of life); and
Changes in best-corrected visual acuity, including a gain of 3 or more lines without vitrectomy.
The investigators found that in patients who received intravitreal ocriplasmin, the proportion of eyes with resolution of vitreomacular adhesion, nonsurgical closure of macular holes, and a gain of 3 or more lines in best-corrected visual acuity and the rate of ocular adverse events were higher. Resolution of vitreomacular adhesion was achieved in 26.5% of ocriplasmin-injected eyes and in 10.1% of placebo-injected eyes (P<.001). There was nonsurgical closure of macular holes in 40.6% of ocriplasmin-injected eyes and 10.6% of placebo-injected eyes (P<.001). Most of the ocular adverse events were transient and included those known to be associated with vitreous detachment (eg, vitreous floaters, photopsias, and blurred vision).
More patients in the ocriplasmin group also reported injection-related pain. The ocriplasmin-injected and placebo-injected eyes did not significantly differ in terms of retinal tears or detachments. Although there was no statistically significant (P≤.05) difference in the primary endpoint in patients with an epiretinal membrane (ERM) or in patients who were pseudophakic, there were differences in patients who were phakic and without an ERM and on the basis of sex (Table).
| Subgroup | Ocriplasmin, % (n = 464) | Placebo, % (n = 188) | P Value |
|---|---|---|---|
| Lens status | |||
| • Phakic | 34.2 | 12.6 | <.001 |
| • Pseudophakic | 13.4 | 3.8 | .051 |
| Without ERM | 37.4 | 14.3 | <.001 |
| With ERM | 8.7 | 1.5 | .046 |
| Men | 18.7 | 5.5 | .01 |
| Women | 30.3 | 13 | <.001 |
ERM = epiretinal membrane
Source...